An Observational Study of Patients With Chronic Kidney Disease

NCT05774392 | Withdrawn

• 1 other identifier: TARGET-KIDNEY
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

TARGET-KIDNEY is an observational research study to conduct a comprehensive review of outcomes for patients with chronic kidney disease (CKD) and end-stage renal disease (ESKD).

Conditions

End Stage Kidney Disease; Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (2)

• To characterize the natural history of disease in patients with CKD/ESKD.

  20 Years

• To assess safety and effectiveness of CKD/ESKD treatments and treatments for complications of either condition

  20 Years

Secondary Outcomes (3)

• To evaluate provider management practices in the treatment of patients with CKD/ESKD

  20 Years

• To evaluate longitudinal and patient reported outcomes in CKD/ESKD

  20 Years

• To select and evaluate quality of care measures for patients with CKD/ESKD

  20 Years

Study Arms (2)

Disease Cohort

Other: Observational

Engaged Cohort

Other: Observational

Interventions

Observational OTHER

Observational

Disease Cohort; Engaged Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include adults who are being managed for Stage 1-5 CKD or received a transplant for ESKD.

You may qualify if:

• Adult\* patients at the time of enrollment with a diagnosis of CKD/ESKD by ICD-10 code in the EHR interface

You may not qualify if:

• Death
• Manual removal (sponsor or site request)
• No EHR interface encounter \> 3 years
• Engaged Cohort
• Adult \* patients diagnosed and managed for CKD/ESKD invited to participate
• Ability to provide written informed consent
• Patient expressed desire to withdraw consent to complete PROs
• Failure to complete PROs within 24 weeks of initial invitation
• Greater than 24 months lapse of survey completion after baseline surveys completed
• Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort

Sponsors & Collaborators

• Target PharmaSolutions, Inc.: lead

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood serum

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: April 1, 2025
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12